Vivos Therapeutics, Inc. (“Vivos” or the
“Company’’) (NASDAQ: VVOS), a medical technology company focused on
developing innovative treatments for patients suffering from
dentofacial abnormalities and/or mild-to-moderate obstructive sleep
apnea (OSA) and snoring in adults, today reported financial results
and operating highlights for the third quarter and nine months
ended September 30, 2023.
Third Quarter 2023 Financial and
Operating Summary
|
● |
Revenue was $3.3 million for the third quarter of 2023 and $10.6
million for the nine months ended September 30, 2023, compared to
$4.2 million and $12.1 million for the three and nine months ended
September 30, 2022, respectively, mainly due to lower product
revenue and Vivos Integrated Provider (“VIP”) enrollments offset by
increased revenue from home sleep testing services and seminars
conducted at the Vivos Institute in Denver. Importantly, Vivos
believes that governmental investigations of third parties with
non-FDA approved products in the sleep apnea treatment space has
adversely impacted new Vivos case starts and VIP enrollments during
2023. |
|
|
|
|
● |
Gross profit was $1.9 million for the third quarter of 2023 and
$6.3 million for the nine months ended September 30, 2023, compared
to $2.5 million and $7.6 million for the comparable periods in
2022, respectively, attributable primarily to the decrease in
revenue; |
|
|
|
|
● |
Gross margin was 57% for the third quarter of 2023, compared to 59%
during the prior year period. For the nine months ended September
30, 2023 gross margin was 60%, compared 63% for the same period in
2022; |
|
|
|
|
● |
Operating expenses for the third quarter of 2023 decreased by a
significant amount ($2.5 million, or 32%) versus the third quarter
of 2022, reflecting Vivos’ previously announced cost-cutting
initiatives including personnel and related expenses. For the nine
months ended September 30, 2023 operating expenses decreased by
$7.3 million or 27%, compared to the same period in 2022; |
|
|
|
|
● |
Vivos’ cost-cutting initiatives also led to significant
year-over-year reductions of net loss of $3.3 million, or a 61%
reduction, and $8.4 million, or a 47% reduction, for the three and
nine months ended September 30, 2023, respectively, compared to the
same periods in 2022. Vivos is aiming to utilize its cost
reductions to set the stage for cash flow positive operations next
year should revenue increase as planned; |
|
|
|
|
● |
Cash and cash equivalents were $1.0 million at September 30, 2023 ,
but subsequent to quarter end, in November 2023, Vivos completed a
private placement for net proceeds of approximately $3.5 million,
to augment its liquidity position; |
|
● |
As of September 30, 2023, patients treated with The Vivos Method
totaled approximately 40,000, compared to over 31,000 as of the
third quarter of 2022. Vivos has also trained more than 1,850
dentists in the use of The Vivos Method and Vivos’ related
value-added services, compared to over 1,650 as of the third
quarter 2022; |
|
|
|
|
● |
Subsequent to quarter end, in October 2023, Vivos announced two key
strategic agreements with Ormco, a division of publicly-traded
Envista Holdings Corporation, and On Demand Orthodontist (ODO),
offering Vivos’ national network of providers access to Spark™
Clear Aligners. The agreements will expand Vivos’ current product
line and are expected to create near term additional revenue
opportunities; |
|
|
|
|
● |
Also in October, Vivos announced an exclusive distribution
agreement with NOUM DMCC (“Noum”), a Dubai-based company focused on
diagnostic testing and treatment product distribution for
healthcare providers and hospital networks treating obstructive
sleep apnea patients throughout the Middle East-North Africa (MENA)
region. Subject to regulatory approvals, Vivos could see revenue
from this collaboration in 2024; |
|
|
|
|
● |
Later in October, Vivos announced that its flagship
daytime-nighttime appliance (DNA) will be tested in a clinical
trial at Stanford Medicine. The protocol has been finalized and
participant enrollment will begin in early 2024. Study participants
with moderate to severe OSA will be randomly assigned to either
treatment with Vivos’ DNA appliance or CPAP (continuous positive
airway pressure) machine, the current industry standard for OSA
treatment. Sleep studies will be performed prior to and following a
course of treatment using in-lab polysomnography to assess changes
in the patients’ apnea-hypopnea index (AHI); |
|
|
|
|
● |
On October 27, 2023, Vivos effected a 1-for-25 reverse stock split
of its issued and outstanding common stock. The reverse stock split
was approved at Vivos’ 2023 Annual Meeting of Stockholders on
September 22, 2023; and |
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|
|
|
● |
In November 2023, Vivos amended its national distribution agreement
with Lincare, a leading supplier of in-home respiratory therapy
products and services for approximately 1.8 million patients,
giving Lincare a six-month exclusivity period to distribute certain
designated Vivos devices. The agreement follows the successful
conclusion of a distribution pilot with Lincare, and marks an
important milestone in Vivos’ strategy to engage with leading
durable medical equipment (DME) companies in the United
States. |
Kirk Huntsman, Vivos’ Chairman and Chief
Executive Officer, stated, “During the third quarter and throughout
the past year, we have expanded our strategic relationships in
order to improve our distribution channels, patient referral
sources and opportunities to increase our revenues. Simultaneously,
we have worked to substantially reduce our cash burn, bolster our
liquidity position and enhance our capital structure. We have made
great progress on all these fronts, demonstrated in our quarterly
results by achieving a 32% year-over-year reduction in operating
expenses. With our progress to date, we continue to plan for
becoming cash flow positive from operations by the end of
2024.”
Mr. Huntsman continued, “In addition to our
improved cost structure and reduced operating expenses, we have
established key, strategic relationships to expand our product line
and open up new distribution channels and patient referral networks
for us. These include our distribution agreements with Ormco, On
Demand Orthodontist, and Noum in the Middle East/North Africa
(MENA) region. More recently, we signed a national distribution
agreement with Lincare, which unfortunately was delayed in its
launch due to third-party related technical issues that were beyond
our control but have now been resolved. This relationship with a
major DME is a perfect example of the type of relationship with the
potential to drive failed CPAP patients into Vivos treatment. Over
time, we believe these relationships will generate a substantial
number of patient referrals for our extensive network of
Vivos-trained dentists, bring significant new growth and revenue
opportunities to Vivos as well as augment and accelerate our
existing VIP and DSO enrollment efforts.”
“Along with these favorable developments, we
have also taken steps to improve our liquidity and capital
structure. We recently closed a private placement for gross
proceeds of $4 million, providing us additional financing to pursue
our growth plans. In addition to this, in October, we effected a
1-for-25 reverse stock split. We believe these actions will help us
to regain compliance with Nasdaq listing requirements, make the
prevailing price of our common stock more attractive to a larger
group of institutional investors, and provide us with the capital
resources necessary to implement our long-term growth strategies
and help bolster our stockholders’ equity.”
“In summary, while the current economic
environment is challenging, Vivos has taken steps to meet those
challenges. We have made considerable progress in decreasing costs
from our business, increasing our liquidity, improving our capital
structure, expanding our product line and creating new referral
sources and revenue opportunities for our company. However,
decreasing costs through personnel reductions can often lead to
near-term revenue shortfalls, which is in part what we saw in the
third quarter. Looking ahead, our mission remains the same – our
goal is to rid the world of the debilitating condition of sleep
apnea. We continue to believe that our expanding portfolio of
proprietary products are the best market solution for treating
sleep apnea and related breathing conditions for which we have
several FDA approvals. We will continue to look at and execute on
opportunities to expand our product offerings and business
collaborations with the goal of driving increased revenues. We
intend to make further progress with our strategic revenue
initiatives during the rest of this year as well as in 2024. By
doing so, we believe Vivos will resume its revenue growth and
achieve cash flow positive operations and profitability in the
foreseeable future,” Mr. Huntsman concluded.
Vivos encourages investors and other interested
parties to join its conference call today at 5:00 p.m. Eastern time
(details below), where management will discuss further details on
topics including: (i) Vivos’ expanded product line and revenue
potential, (ii) the potential significant impact of Vivos’ recent
strategic collaborations on Vivos’ near-term revenue growth, (iii)
an update on Vivos’ DME sales and marketing efforts; (iv)
additional programs for dentists to enroll with Vivos, and (v)
Vivos’ current cash position and actions taken to reduce
expenses.
In addition, further information on Vivos’
financial results is included on the attached unaudited condensed
consolidated balance sheets and statements of operations, and
additional explanations of Vivos’ financial performance are
provided in the Vivos’ Quarterly Report on Form 10-Q for the three
and nine months ended September 30, 2023, which will be filed with
the Securities and Exchange Commission (“SEC”). The full 10-Q
report will be available on the SEC Filings section of the Investor
Relations section of Vivos’ website at
https://vivos.com/investor-relations.
Conference Call
To access Vivos’ investor conference call,
please dial (844) 826-3033, or for international callers, (412)
317-5185. A replay will be available shortly after the call and can
be accessed by dialing (844) 512-2921, or for international
callers, (412) 317-6671. The passcode for the live call and the
replay is 10184114. The replay will be available until November 28,
2023.
A live webcast of the conference call can be
accessed on Vivos’ website at https://vivos.com/investor-relations.
An online archive of the webcast will be available on the Company’s
website for 30 days following the call.
About Vivos Therapeutics,
Inc.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a
medical technology company focused on developing and
commercializing innovative diagnostic and treatment methods for
patients suffering from breathing and sleep issues arising from
certain dentofacial abnormalities such as mild-to-moderate
obstructive sleep apnea (OSA) and snoring in adults. The Vivos
Method represents the first clinically effective nonsurgical,
noninvasive, nonpharmaceutical and cost-effective solution for
treating mild to moderate OSA. It has proven effective (within the
scope of the FDA cleared uses) in approximately 40,000 patients
treated worldwide by more than 1,850 trained dentists.
The Vivos Method includes the Vivos Complete
Airway Repositioning and/or Expansion (CARE) appliance therapy and
associated protocols that alter the size, shape and position of the
soft tissues that comprise a patient’s upper airway and/or palate.
The Vivos Method opens airway space and may significantly reduce
symptoms and conditions associated with mild-to-moderate OSA, such
as lowering Apnea Hypopnea Index scores. Vivos also markets and
distributes SleepImage diagnostic technology under its VivoScore
program for home sleep testing in adults and children. The Vivos
Integrated Practice (VIP) program offers dentists training and
other value-added services in connection with using The Vivos
Method.
For more information, visit
www.vivos.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release, the conference call referred
to herein, and statements of the Company’s management made in
connection therewith contain “forward-looking statements” (as
defined in Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended)
concerning future events. Words such as “may”, “should”, “expects”,
“projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”,
“goal”, “estimates” and variations of such words and similar
expressions are intended to identify forward-looking statements.
These statements involve known and unknown risks and are based upon
several assumptions and estimates, which are inherently subject to
significant uncertainties and contingencies, many of which are
beyond Vivos’ control. Actual results (including, without
limitation, the results of the Company’s revenue generation and
cost cutting initiatives as described herein) may differ materially
and adversely from those expressed or implied by such
forward-looking statements. Factors that could cause actual results
to differ materially include, but are not limited to, the risk
factors described in Vivos’ filings with the Securities Exchange
Commission (“SEC”). Vivos’ filings can be obtained free of charge
on the SEC's website at www.sec.gov. Except to the extent required
by law, Vivos expressly disclaims any obligations or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in Vivos'
expectations with respect thereto or any change in events,
conditions, or circumstances on which any statement is based.
Vivos Investor Relations and Media
Contact:Julie GannonInvestor Relations
Officer720-442-8113jgannon@vivoslife.com
|
|
-Tables Follow- |
|
|
|
|
|
VIVOS THERAPEUTICS INC.Unaudited Condensed
Consolidated Balance Sheets(In Thousands, Except
Per Share Amounts) |
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
988 |
|
|
$ |
3,519 |
|
Accounts receivable, net of allowance of $268 and $712,
respectively |
|
|
228 |
|
|
|
457 |
|
Prepaid expenses and other current assets |
|
|
769 |
|
|
|
1,448 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
1,985 |
|
|
|
5,424 |
|
|
|
|
|
|
|
|
|
|
Long-term
assets |
|
|
|
|
|
|
|
|
Goodwill |
|
|
2,843 |
|
|
|
2,843 |
|
Property and equipment, net |
|
|
3,283 |
|
|
|
3,082 |
|
Operating lease right-of-use asset |
|
|
1,466 |
|
|
|
1,695 |
|
Intangible assets, net |
|
|
433 |
|
|
|
302 |
|
Deposits and other |
|
|
307 |
|
|
|
374 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
10,317 |
|
|
$ |
13,720 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,528 |
|
|
$ |
1,411 |
|
Accrued expenses |
|
|
1,922 |
|
|
|
1,912 |
|
Warrant liability |
|
|
600 |
|
|
|
- |
|
Current portion of contract liabilities |
|
|
2,373 |
|
|
|
2,926 |
|
Current portion of operating lease liability |
|
|
460 |
|
|
|
419 |
|
Other current liabilities |
|
|
284 |
|
|
|
145 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
7,167 |
|
|
|
6,813 |
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities |
|
|
|
|
|
|
|
|
Contract liabilities, net of current portion |
|
|
240 |
|
|
|
112 |
|
Employee retention credit liability |
|
|
1,220 |
|
|
|
- |
|
Operating lease liability, net of current portion |
|
|
1,644 |
|
|
|
1,994 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
10,271 |
|
|
|
8,919 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Preferred Stock, $0.0001 par value per share. Authorized 50,000,000
shares; no shares issued and outstanding |
|
|
- |
|
|
|
- |
|
Common Stock, $0.0001 par value per share. Authorized 200,000,000
shares; issued and outstanding 1,197,258 shares as of September 30,
2023 and 920,592 shares as December 31, 2022 |
|
|
3 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
88,835 |
|
|
|
84,267 |
|
Accumulated deficit |
|
|
(88,792 |
) |
|
|
(79,468 |
) |
Total stockholders’ equity |
|
|
46 |
|
|
|
4,801 |
|
Total liabilities and stockholders’ equity |
|
$ |
10,317 |
|
|
$ |
13,720 |
|
|
|
VIVOS THERAPEUTICS INC.Unaudited Condensed
Consolidated Statements of Operations(In
Thousands, Except Per Share Amounts) |
|
|
|
|
|
Three Months EndedSeptember 30, |
|
|
Nine Months EndedSeptember 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
1,466 |
|
|
$ |
2,014 |
|
|
$ |
4,783 |
|
|
$ |
6,357 |
|
Service revenue |
|
|
1,835 |
|
|
|
2,232 |
|
|
|
5,770 |
|
|
|
5,717 |
|
Total revenue |
|
|
3,301 |
|
|
|
4,246 |
|
|
|
10,553 |
|
|
|
12,074 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (exclusive of depreciation and amortization shown
separately below) |
|
|
1,403 |
|
|
|
1,750 |
|
|
|
4,220 |
|
|
|
4,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
1,898 |
|
|
|
2,496 |
|
|
|
6,333 |
|
|
|
7,635 |
|
|
|
|
57 |
% |
|
|
59 |
% |
|
|
60 |
% |
|
|
63 |
% |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
4,596 |
|
|
|
6,622 |
|
|
|
17,012 |
|
|
|
22,118 |
|
Sales and marketing |
|
|
641 |
|
|
|
1,106 |
|
|
|
1,861 |
|
|
|
3,985 |
|
Depreciation and amortization |
|
|
150 |
|
|
|
175 |
|
|
|
472 |
|
|
|
500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
5,387 |
|
|
|
7,903 |
|
|
|
19,345 |
|
|
|
26,603 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(3,489 |
) |
|
|
(5,407 |
) |
|
|
(13,012 |
) |
|
|
(18,968 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense |
|
|
(53 |
) |
|
|
(36 |
) |
|
|
(198 |
) |
|
|
(152 |
) |
PPP loan forgiveness |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,265 |
|
Excess warrant fair value |
|
|
- |
|
|
|
- |
|
|
|
(6,453 |
) |
|
|
- |
|
Change in fair value of warrant liability, net of issuance costs of
$645 |
|
|
1,600 |
|
|
|
- |
|
|
|
10,362 |
|
|
|
- |
|
Loss on inventory write-down |
|
|
(151 |
) |
|
|
- |
|
|
|
(151 |
) |
|
|
|
|
Other income |
|
|
- |
|
|
|
9 |
|
|
|
128 |
|
|
|
99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,093 |
) |
|
$ |
(5,434 |
) |
|
$ |
(9,324 |
) |
|
$ |
(17,756 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share (basic and
diluted) |
|
$ |
(1.75 |
) |
|
$ |
(6.40 |
) |
|
$ |
(8.09 |
) |
|
$ |
(20.90 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of Common Stock outstanding (basic and diluted) |
|
|
1,197,258 |
|
|
|
849,446 |
|
|
|
1,152,607 |
|
|
|
849,446 |
|
Vivos Therapeutics (NASDAQ:VVOS)
過去 株価チャート
から 5 2024 まで 6 2024
Vivos Therapeutics (NASDAQ:VVOS)
過去 株価チャート
から 6 2023 まで 6 2024